Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
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Immucor is investigating reports of echo qc failures due to equivocal and weak positive reactions in antibody screen when using wbcorqc vial 2 (lot 233161). the expected result is negative. visually the reactions have an atypical appearance with irregular areas of adherence and pinholes in the button.